1992 -
Working Towards Harmonization
in Medical Device Regulation
in Medical Device Regulation
1992 - |
Working Towards Harmonization in Medical Device Regulation |
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| GHTF > Study Groups > Study Group 1 (SG1) > SG 1 Proposed Documents |
Title |
Description |
Posted Date |
Comments Due: |
Comments To: |
|---|---|---|---|---|
| SG1(PD)/N063 | Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices [Word] [PDF] | 7 July 2009 | 7 January 2010 | Nancy Shadeed or Benny Ons |
| SG1(PD)/N063 | Comment Template for SG1(WD)/N063 [Word] | 25 March 2009 | ||
| SG1(WD)/N065 | Registration of Manufacturers and other Parties and Listing of Medical Devices [Word] [PDF] | 2 March 2009 | 2 September 2009 | Ginette Michaud |
| SG1(WD)/N065 | Comment Template for SG1(WD)/N065 [Word] | 2 March 2009 |
Updated 7 July 2009
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